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Chemotherapy Dose Adjustment for Gastrointestinal Cancer Patients with DPD Deficiency Using Fluorouracil, Capecitabine, and Oxaliplatin

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with gastrointestinal cancers, which affect the digestive system. The study is particularly interested in patients who lack a specific liver enzyme called dihydropyrimidine dehydrogenase (DPD). This enzyme is important because it helps break down certain chemotherapy drugs. The trial will use chemotherapy treatments that include fluorouracil and capecitabine, which are types of drugs known as fluoropyrimidines. These drugs are often used in combination with another drug called oxaliplatin. The purpose of the study is to find the best way to adjust the doses of these drugs for patients who have a deficiency in the DPD enzyme, to reduce the risk of severe side effects.

Participants in the study will receive chemotherapy treatments that are adjusted based on their levels of a substance called uracilemia, which is measured before treatment begins. The study will compare different dosing strategies to see which one is most effective in preventing early severe side effects during the first two cycles of treatment. These side effects can include issues with blood cells and the digestive system. The study aims to develop guidelines for safely reducing doses in patients with DPD deficiency.

The trial will involve treatments over a period of several weeks, with regular monitoring to assess how patients respond to the adjusted doses. The study will also look at how effective the treatments are in terms of disease progression and overall survival in patients with stage III and stage IV colorectal cancer. By the end of the study, researchers hope to provide clear recommendations for dosing adjustments in patients with gastrointestinal cancers who have a DPD deficiency.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, a pre-treatment screening is conducted to measure uracilemia levels. This is necessary to determine the appropriate dosage of chemotherapy drugs for patients with gastrointestinal cancer who lack a specific liver enzyme.
Step 2
Initial treatment phase
The treatment involves a combination of chemotherapy drugs: fluorouracil, folinic acid, capecitabine, and oxaliplatin.
Fluorouracil and folinic acid are administered intravenously. Capecitabine is taken orally. Oxaliplatin is also administered intravenously.
The treatment regimen is either biweekly (every two weeks) for the FOLFOX regimen or every three weeks for the CAPOX regimen.
Step 3
Monitoring and dose adjustment
During the first two cycles of treatment, the focus is on monitoring for any severe side effects caused by the chemotherapy.
The dosage of the chemotherapy drugs may be adjusted based on the patient's response and any side effects experienced.
Step 4
Continuation of treatment
The treatment continues for up to four cycles, with ongoing monitoring for side effects and adjustments to the dosage as needed.
The goal is to find the optimal dose that minimizes side effects while effectively treating the cancer.
Step 5
Evaluation of treatment efficacy
The effectiveness of the treatment is evaluated by measuring disease-free survival, overall survival, and progression-free survival in patients with specific types of gastrointestinal cancer.
These evaluations help determine the success of the treatment in preventing cancer recurrence and prolonging life.

Who can join the trial?

11 criteria

Patients must have a pre-treatment screening based on a specific test value called **[U]** as recommended by health authorities.
Women who can have children must have a negative pregnancy test before starting the study.
Patients must agree to avoid pregnancy by using reliable birth control methods during the study and for 6 months after finishing treatment.
Patients must be part of a Social Security System or an equivalent system.
Patients must be willing and able to follow the study rules, including attending treatment sessions, scheduled visits, and follow-up exams.
Patients must have an **ECOG PS** score of 2 or less, which is a measure of their ability to perform daily activities.
Patients must not have received prior treatment with **FP** (5FU or capecitabine) and should be starting chemotherapy with FP and oxaliplatin for any treatment purpose, including common regimens like FOLFOX or CAPOX.
Patients must be 18 years of age or older.
Patients must be eligible to receive full standard doses of FP and oxaliplatin, even if they have a condition called **DPD deficiency**.
Patients must have adequate bone marrow function, which means their blood cell counts are normal, their kidney function is good (with a filtration rate of at least 60 ml/min), and their liver function tests are within acceptable limits.
Patients must have signed a written informed consent form before any study-specific procedures. If a patient cannot sign, a trusted person can confirm the patient's consent in writing.

Who cannot join the trial?

8 criteria

Patients who have previously been treated with **fluoropyrimidine (FP)**, which is a type of cancer medication.
Patients who do not have **gastrointestinal (GI) cancer**, which refers to cancer in the digestive system.
Patients who do not have available **pre-treatment uracilemia ([U])** levels. Uracilemia is a measure of uracil in the blood, which is important for adjusting medication doses.
Patients who are not starting chemotherapy that combines **FP (5FU or capecitabine)** and **oxaliplatin**. These are specific cancer drugs used together for treatment.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are not male or female, as both genders are included in the study.
Patients who are not considered part of a vulnerable population, which means they do not have additional health or social factors that require special consideration.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Assistance Publique Hopitaux De Paris
Verified
Paris, France
Besancon University Hospital Center
Verified
Besançon, France
CHRU De Nancy
Responsive
Vandoeuvre Les Nancy, France

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Investigated drugs

Fluoropyrimidine-based Chemotherapy: This is a type of cancer treatment that uses drugs to kill cancer cells. It is often used to treat gastrointestinal cancers. The trial is focused on adjusting the dose of this chemotherapy for patients who have a deficiency in an enzyme called DPD, which can affect how the body processes the medication. The goal is to reduce the risk of severe side effects by tailoring the dose to each patient's needs.

What is already known about the treatment

5-Fluorouracil (5FU)
This medication is administered intravenously and is used in chemotherapy for treating gastrointestinal cancers. It is currently well-established in medical literature as a standard treatment for various cancers, particularly those affecting the digestive system. The main therapeutic indication is for patients with gastrointestinal cancer who have not previously been treated with fluoropyrimidines. At the molecular level, 5FU works by inhibiting the synthesis of DNA in cancer cells, thereby preventing their growth and division. It is classified as an antimetabolite, which interferes with the normal metabolism of cells.
Capecitabine
This medication is taken orally in the form of tablets and is used in chemotherapy for gastrointestinal cancers. It is widely recognized in medical literature as an effective treatment option for certain types of cancer, especially those in the digestive tract. The primary therapeutic indication is for patients with gastrointestinal cancer who have not been treated with fluoropyrimidines before. Capecitabine is a prodrug that is converted into 5-fluorouracil in the body, where it inhibits DNA synthesis in cancer cells, stopping their growth. It belongs to the pharmacological class of antimetabolites, which disrupt the normal metabolic processes of cells.

Investigated diseases

Gastrointestinal Cancer – This term refers to a group of cancers that affect the digestive system, including the stomach, liver, pancreas, intestines, and other organs. These cancers can develop in any part of the gastrointestinal tract and may cause symptoms such as abdominal pain, weight loss, and changes in bowel habits. The progression of gastrointestinal cancer varies depending on the specific type and location of the cancer. It often begins with the growth of abnormal cells in the lining of the digestive organs, which can form tumors. Over time, these tumors may invade surrounding tissues and spread to other parts of the body. Early detection and monitoring are crucial for managing the disease effectively.